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Cutivate Lotion

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Cutivate Lotion

Cutivate Lotion Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cutivate (fluticasone propionate) Lotion is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis. It is a topical (for the skin) steroid. This medication is available in generic form. Common side effects include mild skin itching, burning, peeling, dryness, changes in color of treated skin, headache, thinning or softening of skin, skin rash or irritation around mouth, swollen hair follicles, blisters, pimples, or crusting of treated skin, or stretch marks.

The recommended dose is to apply a thin film of Cutivate Lotion to the affected skin areas once daily. Rub in gently. It is not likely other drugs you take orally or inject will have an effect on topically applied Cutivate. Tell your doctor all medications and supplements you use. During pregnancy, Cutivate should be used only if prescribed. It may be harmful to a fetus. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Cutivate (fluticasone propionate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cutivate Lotion in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when fluticasone topical is applied to the skin, side effects can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have signs of absorbing fluticasone topical through your skin, such as:

  • blurred vision, or seeing halos around lights;
  • headache, back ache, weakness, confusion, mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face;
  • muscle weakness, feeling tired; or
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Less serious side effects may include:

  • mild skin itching, burning, peeling, or dryness;
  • changes in color of treated skin;
  • thinning or softening of your skin;
  • skin rash or irritation around your mouth;
  • redness or crusting around your hair follicles;
  • blisters, pimples, or crusting of treated skin; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cutivate Lotion (Fluticasone Propionate Lotion) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cutivate Lotion FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

In 2 multicenter vehicle-controlled clinical trials of once-daily application of CUTIVATE® Lotion by 196 adult and 242 pediatric patients, the total incidence of adverse reactions considered drug related by investigators was approximately 4%. Events were local cutaneous events, usually mild and self-limiting, and consisted primarily of burning/stinging (2%). All other drug-related events occurred with an incidence of less than 1%, and inclusively were contact dermatitis, exacerbation of atopic dermatitis, folliculitis of legs, pruritus, pustules on arm, rash, and skin infection.

The incidence of drug-related events on drug compared to vehicle (4% and 5%, respectively) was similar. The incidence of drug-related events between study populations of 242 pediatric patients (age 3 months to < 17 years) and 196 adult patients (17 years or older) (4% and 5%, respectively) was also similar.

In an open-label study of 44 pediatric patients applying CUTIVATE® Lotion to at least 35% of body surface area twice daily for 3 or 4 weeks, the overall incidence of drug-related adverse events was 14%. Events were local, cutaneous, and inclusively were dry skin (7%), stinging at application site (5%), and excoriation (2%).

Table 2: Drug Related Adverse Events from Controlled Clinical Trials (n=438)

Adverse Events CUTIVATE® Lotion
N=221
Vehicle
N=217
Burning/Stinging skin 4 (2%) 3 (1%)
Contact Dermatitis 0 1 ( < 1%)
Exacerbation of Atopic dermatitis 0 1 ( < 1%)
Folliculitis of legs 2 ( < 1%) 0
Irritant Contact Dermatitis 0 1 ( < 1%)
Pruritus 1 ( < 1%) 1 ( < 1%)
Pustules on Arms 1 ( < 1%) 0
Rash 1 ( < 1%) 2 ( < 1%)
Skin Infection 0 3 (1%)

Table 3: Drug Related Adverse Events From Pediatric Open Label Trial (n=44)

Adverse Events CUTIVATE® Lotion Twice Daily
Dry skin at multiple sites 3 (7%)
Stinging at Application Sites 2 (5%)
Excoriation 1 (2%)

The table below summarizes all adverse events by body system that occurred in at least 1% of patients in either the drug or vehicle group in controlled clinical trials.

Table 4: Adverse Events Occurring in ≥ 1% of Patients from Either Arm from Controlled Clinical Trials (n=438)

Body System CUTIVATE®Lotion
N = 221
Vehicle Lotion
N = 217
Any Adverse Event 77 (35%) 82 (38%)
Skin
  Burning and Stinging 4 (2%) 3 (1%)
  Pruritus 3 (1%) 5 (2%)
  Rash 2 (<1%) 3 (1%)
  Skin Infection 0 3 (1%)
Ear, Nose, Throat
  Common Cold 9 (4%) 5 (2%)
  Ear Infection 3 (1%) 3 (1%)
  Nasal Sinus Infection 2 (<1%) 4 (2%)
  Rhinitis 1 (<1%) 3 (1%)
  Upper Respiratory Tract Infection 6 (3%) 7 (3%)
Gastrointestinal
  Normal Tooth Eruption 2 (< 1%) 3 (1%)
  Diarrhea 3 (1%) 0
  Vomiting 3 (1%) 2 (<1%)
Lower Respiratory
  Cough 7 (3%) 6 (3%)
  Influenza 5 (2%) 0
  Wheeze 0 3 (1%)
Neurology
  Headache 4 (2%) 5 (2%)
Non-Site Specific
  Fever 8 (4%) 8 (4%)
  Seasonal Allergy 2 ( < 1%) 3 (1%)

During the clinical trials, eczema herpeticum occurred in a 33-year-old male patient treated with CUTIVATE® Lotion. Additionally, a 4-month-old patient treated with CUTIVATE® Lotion in the open-label trial had marked elevations of the hepatic enzymes AST and ALT.

Post Marketing Experience

Systemic adverse events with CUTIVATE® Cream and CUTIVATE® Ointment have included: immunosuppression/Pneumocystis carinii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/ glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).

The following localized adverse reactions have been reported during post approval use of CUTIVATE® Lotion: erythema, edema/swelling, bleeding, and a reported lack of efficacy.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Cutivate Lotion (Fluticasone Propionate Lotion) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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